Inside MedTech Compliance: Benchmarking the People, Processes, and Costs Behind Regulatory and Quality Excellence

Industries Profiled:
Medical Device; Health Care; Pharmaceutical; Diagnostic; Biopharmaceutical; High Tech; Biotech; Medical; Technology; Consulting; Science


Companies Profiled:
3M - DDSD; Abbott; Abbott Vascular; Accelerate Diagnostics; Acceleron Pharma; Aesculap; Agilent; Alcon; B. Braun; Baxter Healthcare; Beckman Coulter; BIOTRONIK; Boston Scientific; CMR Surgical Ltd; ConMed; Cook Medical; eNeura Therapeutics; Fisher & Paykel Healthcare; FzioMed; Getinge; GRIFOLS; Haemonetics Corporation; Halma; insStem; Johnson & Johnson; Lentigen Corporation; Lifecore Biomedical; Meril Life Sciences; Minnetronix Medical; Molnlycke Health Care; NeedleTech Products; neMedIO; nSpire Health; Onconova Therapeutics; Ortho Clinical Diagnostics; PerkinElmer; Philips; QMS Consulting; Quest Medical; Radius Health; ReShape Lifesciences; ResMed; Sartorius Stedim; Smith & Nephew; Stryker; Teleflex; Thermo Fisher Scientific; Verastem Oncology; Waters Corporation; Wright Medical; Zimmer Biomet; ZimVie

Study Snapshot

Best Practices, LLC analyzed RAQA benchmarks from 63 MedTech business units, drawing on data contributed across multiple time periods. The most recent update includes in-depth insights from 10 leading organizations. Benchmark participants were stratified by product type—technology-enabled devices, robotics surgical devices, and traditional medical devices—and by company size and maturity, including emerging, mid-size, and large organizations.

Key topics covered in this report include:

• Shifting RAQA Investment Strategies and Cost Structures
• Impact of Business Focus and Product Mix on Compliance Demands
• RAQA Organizational Models and Shared Services Optimization
• Regional Staffing, Outsourcing and Workforce Evolution
• Compliance Spending Across the Product Lifecycle and Geographic Markets
• Leveraging AI, Data Analytics, and Digital Tools for Cost Containment
• Regulatory Stressors and Corporate Integrity Agreements Driven Investment Priorities

• Total Outsourced Staff: Quality roles are outsourced more frequently (28%) than Regulatory roles (5%), though most RAQA functions continue to rely primarily on in-house employees.

• Innovation with Artificial Intelligence: AI deployment is advancing rapidly, with most companies in the pilot or early use stage. Organizations should continue targeted pilots to spot areas where AI delivers the most value to RAQA functions—and scale those quickly to maximize productivity gains.

• One-page executive summary

• Overview of participating MedTech companies
• Most recent benchmark cohort
• Company segmentation by product type: technology-enabled medical devices, robotics surgical devices + other digital platforms, and traditional medical devices
• Participant stratification by company size and maturity: emerging, mid-size, and large MedTech organizations

• Ecosystem framework analyzing 15+ key factors impacting regulatory and quality performance

• Average regulatory investment as a percentage of revenue
• Regulatory investment as a percentage of revenue: segmented by product type
• Regulatory investment as a percentage of revenue: value of competitive effectiveness
• Regulatory investment patterns in the context of corporate integrity agreements
• Average quality investment as a percentage of revenue
• Quality investment as a percentage of revenue: segmented by product type
• Quality investment patterns in the context of corporate integrity agreements

• Business unit classification based on legacy responses – organizational type segmentation
• Business unit classification based on most recent responses – updated organizational view
• Therapeutic area coverage of new benchmark class – product portfolio reach across clinical markets
• Annual revenue reporting – legacy data on reported and projected figures in USD
• Annual revenue reporting – new data on reported and projected figures in USD
• Annual revenue distribution – individual response-level data
• Product portfolio composition by regulatory class – Class I, II, III mix from legacy data
• Product classification trends – comparison of Class I, II, III mix across time periods
• Product mix breakdown by business focus – updated classification of portfolio share

• Total RAQA function spend – reported values from most recent dataset
• Product and portfolio volume – new data on total unique products and product families influencing RAQA cost
• Legacy and new data on RAQA cost benchmarks by product classification – spend per Class I and II product and family
• RA and QA spend ratio trends – comparison of legacy and current datasets
• RA and QA spend ratio analysis – current data analysis
• Spend ratio comparison – legacy + current vs. current RA and QA investment patterns
• RAQA spend allocation – new data on functional mix of total investment across key RAQA areas
• RAQA cost exclusions – new data on functions or departments not included in reported RAQA spend
• Administrative and shared services exclusions – new data on compensation and overheads not counted toward RAQA costs

• New data on RAQA launch cost distribution by geographic market – percent of total spend by country
• New data on total RAQA investment per product across the lifecycle – development, submission, and launch costs in the U.S. and Europe
• New data on RAQA cost allocation by lifecycle stage – spend distribution across product development phases
• New data on RAQA launch costs as a percentage of peak-year sales – financial impact of launch vs. maintenance
• Regional growth trends – organizational performance shifts compared to three years ago
• New data on clinical trial recruitment patterns – pre- vs. post-pandemic patient enrollment by region
• Market exits due to compliance or regulatory issues – recent trends in geographic withdrawal

• RAQA organizational structure – current primary operating models across participating companies
• Current RAQA structure by company size – comparison between large vs. mid-small MedTech organizations
• Current geographic approach to RAQA operations – regional vs. global alignment of RAQA functions
• Current RAQA shared services model – usage of centers of excellence (CoE) to deliver specialized support
• Current RAQA shared services impact – effectiveness in extending functional expertise
• Current RAQA shared services cost benefits – role in improving efficiency and cost containment
• Current RAQA shared services model analysis – comparison of usage, expertise extension, and cost containment
• Current and legacy data on RAQA structure strengths – key advantages of organizational and geographic models
• Current and legacy data on RAQA structure weaknesses – challenges and limitations within RAQA operating frameworks

• Current global RAQA staffing headcounts – total FTEs including employees and contractors
• Current regional distribution of regulatory affairs staff – percentage breakdown across global markets
• Current regional distribution of quality affairs staff – percentage breakdown by geography
• Current RAQA outsourcing levels – share of contract employees and external consultants by function
• Current RAQA staffing cost as a percentage of revenue – global personnel spend relative to total sales
• Current breakdown of RA vs. QA staffing expenses – contribution of each function to overall RAQA spend
• RAQA workforce trends – changes in staffing over the past five years and projections for the next five years

• Current value assessment of regulatory key performance indicators (KPIs)
• Current value assessment of quality KPIs
• Regulatory stressors driving compliance-cost increases – combined current and legacy insights
• Current effectiveness ratings for strategies that manage rising RAQA compliance costs

• Current data analytics structure and utilization of device-generated data
• Current perspectives on intellectual property and data ownership from robotic and digital devices

• Top AI / digital opportunity areas for cost reduction – current insights
• Current adoption levels of AI and digital tools for RAQA cost control
• Current effectiveness ratings of AI and digital solutions in lowering compliance costs
• Usage-versus-effectiveness matrix for AI and digital technologies – current snapshot
• Current maturity stages of AI deployment within RAQA functions

• Participation in corporate integrity agreements (CIA) or consent decrees – combined current and legacy view
• Current status of CIA / consent-decree participation
• CIA impact on regulatory investment as a share of revenue – current data
• CIA impact on quality investment as a share of revenue – current data
• Regulatory and quality investment patterns under CIA conditions – current-year view

• Headquarters country of participating RAQA units
• Response-focus level (global, country, or business unit)
• Geographic scope of each response